Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

No Additional Omapro Trials Needed, FDA Tells ChemGenex In Complete Response Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA reservations mirror those outlined about need for validated assay test at March 22 ODAC meeting.
Advertisement

Related Content

Teva’s Synribo: Salvage Therapy, But Not Personalized Medicine
Teva’s Synribo Clears FDA For Third-Line Chronic Myeloid Leukemia
A Tale Of Two Targeted Therapies
Pazdur’s Tale Of Two Targeted Therapies
FDA will let ChemGenex file Omapro in third-line CML with no mutation test required
FDA will let ChemGenex file Omapro in third-line CML with no mutation test required
U.S. FDA Says Australian ChemGenex Needs Companion Diagnostic For Omapro
Omapro Needs Companion Diagnostic, Advisory Committee Says
Omapro Needs Companion Diagnostic, Advisory Committee Says
Australian ChemGenex's Omapro Faces Scaled Back Efficacy Claims After Trial Shortcomings

Topics

Advertisement
UsernamePublicRestriction

Register

PS070475

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel